Atrial FibrillationNCT04104191
The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
A study testing L-1000AF System in people with Atrial Fibrillation, run by LIVMOR, Inc. at 2 sites in United States.
Trial summary
The LIVMOR Data Collection Study is a multicenter, IDE Exempt Study to generate a library of device-specific signals collected noninvasively. The study was not designed to evaluate specific hypothesis or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- L-1000AF System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jul 2017to 14 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing, able and sufficiently motivated to attend all study visits and participate in all study activities; and
- Physically and mentally capable of providing informed consent and are at least 18 years of age or of legal age to provide consent as required by local and national requirements.
Who cannot join
- Has any unstable or significant medical condition that is likely to interfere with study procedures or subjects medical care;
- Has any implantable electronic medical device;
- Has significant hearing, visual or cognitive impairment as determined by the Investigator; and
- Participating in any other clinical study without written consent from the Sponsor
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA North Texas Health Care System
Dallas, Texas, 75216
Texas Health Dallas
Dallas, Texas, 75231
About this study
The LIVMOR Data Collection Study is a multicenter, IDE Exempt Study to generate a library of device-specific signals collected noninvasively. The study was not designed to evaluate specific hypothesis or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were retrospectively used for the development and subsequently the validation of the L-1000AF System. The L-1000AF System is a wrist worn system intended to provide continuous remote monitoring of atrial fibrillation (AF) episodes. The system is intended for use under the care of a physician and is not intended for the diagnosis of AF.
Read the detailed description
LIVMOR is developing a series of wearable medical device systems intended to promote general wellness and help subjects and physicians manage various diseases that can benefit from increased visibility of physical activity, sleep, weight, blood pressure, stress/recovery levels and cardiac rhythms.
Data from human subjects is necessary to develop and validate LIVMOR devices. LIVMOR completed a multicenter, IDE Exempt Study to generate a library of device-specific signals collected non-invasively using components of the LIVMOR system and simultaneously acquired with ECG Holter data using a commercially available Holter monitor. Data from the analysis of the Holter monitor was adjudicated by physicians skilled in the analysis and interpretation of ECGs compared to the analysis from the LIVMOR AF Detection Algorithm to establish the sensitivity and specificity of the algorithm for detection of AF in comparison to ground truth.
The study was not designed to evaluate specific hypotheses or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were retrospectively used for the development and subsequently the validation of the L-1000AF System.
- Conditions
- Atrial Fibrillation
- Being tested
- L-1000AF System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-1000AF SystemDevice
The L-1000AF System is a wrist worn system that analyzes pulse rate data. The system identifies atrial fibrillation rhythms.
| Study group | Role | What they receive |
|---|---|---|
| L-1000AF System | Experimental | Software device on a wearable device used to detect irregular heart rhythms suggestive of Atrial Fibrillation Receives: Device: L-1000AF System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent Atrial Fibrillation
Simultaneous ECG monitoring indicating Atrial Fibrillation rhythm.
Measured: 10 minutes
Detection of Atrial Fibrillation
A decision of Atrial Fibrillation detection in at least one 192-beat window.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start27 Jul 2017
- Primary completion13 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- LIVMOR, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Texas Health Dallas, North Texas Veterans Healthcare System
- Responsible party
- Sponsor
- Investigators
- Tony Das, MD, Principal investigator, Texas Health DallasSubhash Banerjee, MD, Principal investigator, North Texas Veterans Healthcare SystemKen Persen, Study director, LIVMOR, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104191
- Sponsor's protocol ID
- CIP-1001
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LIVMOR Data Collection Study for the Development and Validation of L-1000AF System
- ClinicalTrials.gov ID
- NCT04104191
- Acronym / sponsor ID
- CIP-1001
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- LIVMOR, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Texas Health Dallas, North Texas Veterans Healthcare System
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LIVMOR Data Collection Study is a multicenter, IDE Exempt Study to generate a library of device-specific signals collected noninvasively. The study was not designed to evaluate specific hypothesis or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were retrospectively used for the development and subsequently the validation of the L-1000AF System. The L-1000AF System is a wrist worn system intended to provide continuous remote monitoring of atrial fibrillation (AF) episodes. The system is intended for use under the care of a physician and is not intended for the diagnosis of AF.
Detailed description
LIVMOR is developing a series of wearable medical device systems intended to promote general wellness and help subjects and physicians manage various diseases that can benefit from increased visibility of physical activity, sleep, weight, blood pressure, stress/recovery levels and cardiac rhythms.
Data from human subjects is necessary to develop and validate LIVMOR devices. LIVMOR completed a multicenter, IDE Exempt Study to generate a library of device-specific signals collected non-invasively using components of the LIVMOR system and simultaneously acquired with ECG Holter data using a commercially available Holter monitor. Data from the analysis of the Holter monitor was adjudicated by physicians skilled in the analysis and interpretation of ECGs compared to the analysis from the LIVMOR AF Detection Algorithm to establish the sensitivity and specificity of the algorithm for detection of AF in comparison to ground truth.
The study was not designed to evaluate specific hypotheses or endpoint, rather it was intended for data collection purposes to generate a library of raw clinical data that were retrospectively used for the development and subsequently the validation of the L-1000AF System.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-1000AF System | Experimental | Device: L-1000AF SystemSoftware device on a wearable device used to detect irregular heart rhythms suggestive of Atrial Fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing, able and sufficiently motivated to attend all study visits and participate in all study activities; and
- Physically and mentally capable of providing informed consent and are at least 18 years of age or of legal age to provide consent as required by local and national requirements.
Key exclusion criteria (4 listed)
- Has any unstable or significant medical condition that is likely to interfere with study procedures or subjects medical care;
- Has any implantable electronic medical device;
- Has significant hearing, visual or cognitive impairment as determined by the Investigator; and
- Participating in any other clinical study without written consent from the Sponsor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-1000AF SystemThe L-1000AF System is a wrist worn system that analyzes pulse rate data. The system identifies atrial fibrillation rhythms. | Device | L-1000AF System |
Primary outcome
Concurrent Atrial Fibrillation
Time frame: 10 minutes
Simultaneous ECG monitoring indicating Atrial Fibrillation rhythm.
Detection of Atrial Fibrillation
Time frame: 10 minutes
A decision of Atrial Fibrillation detection in at least one 192-beat window.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Das, MD principal investigator
Texas Health Dallas
Subhash Banerjee, MD principal investigator
North Texas Veterans Healthcare System
Ken Persen study director
LIVMOR, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-1000AF System in people with Atrial Fibrillation, run by LIVMOR, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concurrent Atrial Fibrillation (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.